Taurine Effect on Glycemic, Lipidic and Inflammatory Profile in Individuals With Type 2 Diabetes

NCT ID: NCT04874012

Last Updated: 2025-09-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 94 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-12
• Study Completion Date: 2025-12-31

Brief Summary

Type 2 diabetes mellitus (DM2) is characterized by chronic hyperglycemia, which is a risk factor for comorbidities and death. Although conventional pharmacotherapy is effective, some individuals do not reach the glycemic targets, requiring adjuvant therapies. Taurine is a semi-essential amino acid with antioxidant and osmoregulatory properties, commonly used as a nutritional supplement. Pre-clinical studies show its effectiveness in reducing blood glucose and cholesterol, but there are no well-conducted clinical studies evaluating the effect of taurine on glycated hemoglobin. Additionally, animal models showed that taurine had a protective effect from diabetic nephropathy. The hypothesize of this study is that taurine administration improves the glycemic, lipid, inflammatory, and anthropometric parameters in DM2 individuals.

Detailed Description

A randomized, double-blind, placebo-controlled clinical trial will be conducted at Hospital de Clínicas de Porto Alegre (HCPA), Brazil. A total of 94 participants with DM2 will be recruited and randomized on a 1:1 ratio to receive 3 g taurine as a powder for oral suspension, twice per day, for 12 weeks or packets containing placebo. Blood will be collected prior to the treatment and after 12 weeks for glycated hemoglobin, fasting glucose, insulinemia, total cholesterol and fractions, triglycerides, C-reactive protein, creatinine, urea, tumor necrosis factor-alpha (TNF-α), interleukin 1 and 6 (IL-1 and IL-6) measures. Urine will be collected at baseline and after 12 weeks for creatine, protein, and albumin measured. Anthropometric parameters and a 24-h dietary recall will be monthly investigated. Fourteen days before the end of the trial, participants will be connected to a continuous glucose monitoring system for glucose monitoring system for glucose variability evaluation. Participants will be contacted by phone weekly to report adverse effects.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Placebo

Participants into the placebo group will receive the same treatment regimen, but with packets of the same appearance and size containing only vehicle.

Group Type: PLACEBO_COMPARATOR

Placebo Comparator

Intervention Type: OTHER

Participants will receive the same treatment regimen and intake recommendation, but packets with the same appearance and size from those taurine ones will contain a vehicle

Taurine

Participants will receive 6 gy taurine divided into twice/day orally administration for 12 weeks.

Group Type: ACTIVE_COMPARATOR

Active comparator Taurine

Intervention Type: DRUG

Participants will receive 3 g taurine, twice a day, as a powder for oral suspension (3 g/packet) for 12 weeks. Participants will be recommended to take the taurine immediately before the breakfast and dinner.

Interventions

Active comparator Taurine

Participants will receive 3 g taurine, twice a day, as a powder for oral suspension (3 g/packet) for 12 weeks. Participants will be recommended to take the taurine immediately before the breakfast and dinner.

Intervention Type: DRUG

Placebo Comparator

Participants will receive the same treatment regimen and intake recommendation, but packets with the same appearance and size from those taurine ones will contain a vehicle

Intervention Type: OTHER

Other Intervention Names

Taurine

Eligibility Criteria

Inclusion Criteria

• Female and male individuals, with clinical diagnosis of DM2 for at least 6 months;
• Age over 30 years;
• BMC equal to or above 18.5 kg/m2, without weight change in the last 3 months;
• HbA1c between 7.5% and 10.5%.

Exclusion Criteria

• Use of herbal supplements, antioxidants, and multivitamins in the last 3 months;
• Pregnancy or lactation;
• Chronic renal failure with glomerular filtration rate calculated by MDRD < 30 mL/h;
• Myocardial infarction in the last than 6 months
• Current neoplasia;
• Chronic use of glucocorticoids;
• Bariatric surgery.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Beatriz D Schaan, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital de Clínicas de Porto Alegre

Locations

Hospital de Clínicas

Porto Alegre, Rio Grande do Sul, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Beatriz D Schaan, PhD

Role: CONTACT

bschaan@hcpa.edu.br

55 51 3359-8000

Rosane Gomez, PhD

Role: CONTACT

rogomez@hcpa.edu.br

55 51 33082823

Facility Contacts

Beatriz D'agord Schaan, PhD

Role: primary

bschaan@hcpa.edu.br

55+513359-8000

Rosane Gomez, PhD

Role: backup

rogomez@hcpa.edu.br

55 51 33082823

References

Caletti G, Herrmann AP, Pulcinelli RR, Steffens L, Moras AM, Vianna P, Chies JAB, Moura DJ, Barros HMT, Gomez R. Taurine counteracts the neurotoxic effects of streptozotocin-induced diabetes in rats. Amino Acids. 2018 Jan;50(1):95-104. doi: 10.1007/s00726-017-2495-1. Epub 2017 Sep 21.

Reference Type: BACKGROUND

PMID: 28936709 (View on PubMed)

Caletti G, Olguins DB, Pedrollo EF, Barros HM, Gomez R. Antidepressant effect of taurine in diabetic rats. Amino Acids. 2012 Oct;43(4):1525-33. doi: 10.1007/s00726-012-1226-x.

Reference Type: BACKGROUND

PMID: 22302366 (View on PubMed)

Chauncey KB, Tenner TE Jr, Lombardini JB, Jones BG, Brooks ML, Warner RD, Davis RL, Ragain RM. The effect of taurine supplementation on patients with type 2 diabetes mellitus. Adv Exp Med Biol. 2003;526:91-6. doi: 10.1007/978-1-4615-0077-3_12. No abstract available.

Reference Type: BACKGROUND

PMID: 12908588 (View on PubMed)

Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gotzsche PC, Krleza-Jeric K, Hrobjartsson A, Mann H, Dickersin K, Berlin JA, Dore CJ, Parulekar WR, Summerskill WS, Groves T, Schulz KF, Sox HC, Rockhold FW, Rennie D, Moher D. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013 Feb 5;158(3):200-7. doi: 10.7326/0003-4819-158-3-201302050-00583.

Reference Type: BACKGROUND

PMID: 23295957 (View on PubMed)

Fukuda N, Yoshitama A, Sugita S, Fujita M, Murakami S. Dietary taurine reduces hepatic secretion of cholesteryl ester and enhances fatty acid oxidation in rats fed a high-cholesterol diet. J Nutr Sci Vitaminol (Tokyo). 2011;57(2):144-9. doi: 10.3177/jnsv.57.144.

Reference Type: BACKGROUND

PMID: 21697633 (View on PubMed)

Gomez R, Caletti G, Arbo BD, Hoefel AL, Schneider R Jr, Hansen AW, Pulcinelli RR, Freese L, Bandiera S, Kucharski LC, Barros HMT. Acute intraperitoneal administration of taurine decreases the glycemia and reduces food intake in type 1 diabetic rats. Biomed Pharmacother. 2018 Jul;103:1028-1034. doi: 10.1016/j.biopha.2018.04.131. Epub 2018 Apr 25.

Reference Type: BACKGROUND

PMID: 29710660 (View on PubMed)

American Diabetes Association. 6. Glycemic Targets: Standards of Medical Care in Diabetes-2021. Diabetes Care. 2021 Jan;44(Suppl 1):S73-S84. doi: 10.2337/dc21-S006.

Reference Type: BACKGROUND

PMID: 33298417 (View on PubMed)

American Diabetes Association. 5. Facilitating Behavior Change and Well-being to Improve Health Outcomes: Standards of Medical Care in Diabetes-2021. Diabetes Care. 2021 Jan;44(Suppl 1):S53-S72. doi: 10.2337/dc21-S005.

Reference Type: BACKGROUND

PMID: 33298416 (View on PubMed)

Other Identifiers

20200559

Identifier Type: -

Identifier Source: org_study_id